Automated dialysis system driven by gravity and vacuum

ABSTRACT

A peritoneal dialysis machine includes: (i) a supply bag; (ii) an apparatus configured to support the supply bag, the supply bag located above the peritoneal cavity of a patient; (iii) a vacuum source; (iv) a patient line configured to be connected to the patient; (v) a drain line configured to be connected to a drain; and (vi) a logic implementor configured to enable (a) fresh dialysate to be gravity fed from the supply bag through the patient line to the peritoneal cavity during a fill cycle and (b) the vacuum source to cause spent dialysate to be pulled from the peritoneal cavity through the drain line to the drain during a drain cycle.

BACKGROUND OF THE INVENTION

In general, the present invention relates to medical fluid deliverysystems that employ a disposable set with sterile fluid pathways. Inparticular, the present invention provides systems, methods andapparatuses for disposable set-based dialysis medical fluid therapies,including but not limited to those using peristaltic pumps, diaphragmpumps, pneumatic pumps and gravity.

Due to various causes, a person's renal system can fail. Renal failureproduces several physiological derangements. The balance of water,minerals and the excretion of daily metabolic load is no longer possibleand toxic end products of nitrogen metabolism (urea, creatinine, uricacid, and others) can accumulate in blood and tissue.

Kidney failure and reduced kidney function have been treated withdialysis. Dialysis removes waste, toxins and excess water from the bodythat would otherwise have been removed by normal functioning kidneys.Dialysis treatment for replacement of kidney functions is critical tomany people because the treatment is life saving.

Hemodialysis (“HD”) and peritoneal dialysis (“PD”) are two types ofdialysis therapies used commonly to treat loss of kidney function. HDremoves waste toxins and excess water from the patient's blood. Thepatient is connected to a hemodialysis machine via catheters into apatient's vein and artery. Blood is pumped from the patient and throughthe inside of hollow, porous tubes of a dialyzer connected to themachine. The machine produces dialysate, which is pumped outside thehollow, porous tubes. A pressure gradient causes excess water to bepulled from the blood, through the pours of the membrane, into thedialysate, where it is carried away. Diffusion and osmosis causes wasteand toxins to move thought the pours into the dialysate to be carriedaway. Cleaned blood is returned to the patient. A large amount ofdialysate, for example about 120 liters, is consumed to dialyze theblood during a single hemodialysis therapy. HD lasts several hours andis generally performed in a treatment center about three or four timesper week.

PD uses a dialysis solution, or “dialysate,” which is infused into apatient's peritoneal cavity via a catheter. The dialysate contacts theperitoneal membrane of the peritoneal cavity. Waste, toxins and excesswater pass from the patient's bloodstream, through the peritonealmembrane and into the dialysate due to diffusion and osmosis, i.e., anosmotic gradient occurs across the membrane. The spent dialysate isdrained from the patient, removing waste, toxins and excess water fromthe patient. This cycle is repeated.

There are various types of PD therapies, including continuous ambulatoryperitoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”),tidal flow APD and continuous flow peritoneal dialysis (“CFPD”). CAPD isa manual dialysis treatment. The patient manually connects an implantedcatheter to a drain, allowing spent dialysate fluid to drain from theperitoneal cavity. The patient then connects the catheter to a bag offresh dialysate, infusing fresh dialysate through the catheter and intothe patient. The patient disconnects the catheter from the freshdialysate bag and allows the dialysate to dwell within the peritonealcavity, wherein the transfer of waste, toxins and excess water takesplace. The introduction of twin bag sets reduced the number ofconnections and disconnections by “Y-ing” the drain line and the freshdialysate bag. Nevertheless, manual PD requires a significant amount oftime and effort from the patient, leaving ample room for improvement.After a dwell period, the patient repeats the manual dialysis procedure,for example, four times per day, each treatment lasting about an hour.

APD is similar to CAPD in that the dialysis treatment includes drain,fill, and dwell cycles. APD machines, however, perform the cyclesautomatically, typically while the patient sleeps. APD machines freepatients from having to manually perform the treatment cycles and fromhaving to transport supplies during the day. APD machines connectfluidly to an implanted catheter, to a source or bag of fresh dialysateand to a fluid drain. APD machines pump fresh dialysate from a dialysatesource, through the catheter, into the patient's peritoneal cavity, andallow the dialysate to dwell within the cavity, and allow the transferof waste, toxins and excess water to take place. The source can bemultiple sterile dialysate solution bags.

APD machines pump spent dialysate from the peritoneal cavity, though thecatheter, to the drain. As with the manual process, several drain, filland dwell cycles occur during APD. A “last fill” occurs at the end ofCAPD and APD, which remains in the peritoneal cavity of the patientuntil the next treatment.

Both CAPD and APD are batch type systems that send spent dialysis fluidto a drain. Tidal flow systems are modified batch systems. With tidalflow, instead of removing all of the fluid from the patient over alonger period of time, a portion of the fluid is removed and replacedafter smaller increments of time.

Continuous flow, or CFPD, systems clean or regenerate spent dialysateand thereby consume a lesser volume dialysate when compared to CAPD orconventional APD. Regeneration systems pump fluid into and out of thepatient, through a loop. Dialysate flows into the peritoneal cavitythrough one catheter lumen and out another catheter lumen. The fluidexiting the patient passes through a reconstitution device that removeswaste from the dialysate, e.g., via a carbon filter and a urea removalcolumn that employs urease to enzymatically convert urea into ammonia.The ammonia is then removed from the dialysate by adsorption prior toreintroduction of the dialysate into the peritoneal cavity. Additionalsensors are employed to monitor the removal of ammonia. CFPD systems aretypically more complicated than batch systems.

Many PD systems use gravity to fill and drain. Patient data published byBrandes et al. shows that flow rates during fill cycle are relativelyconstant and related to the patient's position (supine>sit) and theabsolute head height of the supply bag. Drain cycles however normallytake about twice as long as fill cycles and have an antilog relationshipwith time. Within the drain cycle, about 80% of intra-peritoneum volumeis drained within the first 40% of the total drain time. Similar resultsare found from patient data by Amici et al., and from patient trials forBaxter's HomeChoice and Quantum PD cyclers.

Flow rates of gravity fill and drain are functions of several physicalparameters, including head heights to the patient's peritoneum, cathetertype (resistances), tubing set type, etc. To overcome the fill and drainproblems, some advanced APD machines use pumps to fill and drain. Pumpsprovide active fluid delivery but add complexity and cost. Accordingly,a need exists to provide a relatively low cost PD machine that combinesdesirable aspects of different types of APD systems.

SUMMARY OF THE INVENTION

Described below is a peritoneal dialysis (“PD”) system that combines theadvantages of gravity dialysate delivery and pumped dialysate delivery.In particular, gravity is used to fill the patient, while a vacuumsource or pump is used to drain the patient in one preferred embodiment.The vacuum source can be variable, e.g., from zero to −1.5 psig. Thevacuum source enables patients to sleep on the floor, underneath thedrain bag or otherwise at an elevation that would not allow for adequatedrain flow via gravity.

In one primary embodiment, the system includes a stand. A heater plateis positioned at the top of the stand. The heater plate supports andheats one or more supply bag, such as one or more supply bag and alast-bag (holding an amount of dialysate that will be left in thepatient between automated treatments). The stand is adjustable so thatthe supply bags are supported at an appropriate height above thepatient, e.g., thirty-six inches. A line or tube extends from eachsupply bag to a valve, such as a multi-way pinch valve. The pinch valvesare operated by the vacuum source. A control unit operates the vacuumsource sequence. The control unit includes a microprocessor and memoryin one embodiment, which control the vacuum source. The control unitalso receives signals from a load cell or strain gauge, which is coupledto the drain container. This is done for the monitoring and the controlof ultrafiltration which is generally considered to be the differencebetween the drained fluid volume and the filled fluid volume.

A patient line extends from the multi-way valve. The patient line at itsdistal end includes a connector that connects to a transfer set andcatheter implanted into the patient. A drain line also extends from themulti-way valve. The drain line is connected to a reusable draincontainer, such as a rigid container. A vacuum line extends from therigid container to the vacuum source. In one embodiment, the vacuum lineis located elevationally above the level that the spent fluid will riseto in the drain container. In this configuration, fluid cannot reach thevacuum line, precluding the spent fluid from the drain container fromreaching and potentially damaging the vacuum source. A hydrophobicmembrane can also be placed at the interface between the drain containerand the drain line for this purpose.

In this first embodiment, a priming cycle occurs as follows. The patientpositions the end of the patient line so that its distal end is atsubstantially the same height as the supply bags. For example, theheater or its stand could include a hook onto which the patient hangsthe patient line connector for priming. The control unit controls thevacuum source so that the valves to each of the supply bags, the patientline and the drain line are opened. The control unit is programmed tokeep the valves open for a certain amount of time or until a certainvolume (or weight) of fluid has flowed to ensure that each line isprimed with fluid without dumping too much fresh fluid to drain.

In the first embodiment, a drain cycle is performed, e.g., first toremove the spent last-bag volume of fluid residing in the patient'speritoneum from the night before. Here the control unit causes thevacuum source to open the drain valve and patient line valve, keepingall supply valves closed. The control unit also causes the vacuum sourceto pull a vacuum on the rigid drain container, which is connected to thedrain line. The vacuum pulls spent dialysate from the patient'speritoneum, through the multi-way valve and into the drain container,which fills from the bottom up via gravity. The load cell and controlunit measure the weight of the fluid in the drain container. Weightchanges over time are also measured to determine flow rate. The flowrate is used as feedback to control the amount of vacuum applied to thedrain container, which allows the flow rate of the drain cycle to beoptimized.

The control unit in one embodiment stores one or more patient profile,in which the variable vacuum source is modified to optimize flow andpressure with particular physiological characteristics of the patient.For example, when the patient's peritoneum is relatively full, thecontroller can be set to cause the vacuum source to remove fluid rapidlyand relatively constantly from the patient. This can be done using arelatively low suction pressure because the source of spent fluid isrelatively abundant and flows readily from the peritoneal cavity. As thepatient's peritoneum becomes more and more empty, and the source ofspent fluid becomes increasingly less abundant, the fluid flow starts toslow down. The suction pressure can be decreased to prevent the negativepressure in the patient's peritoneal cavity from causing pain to thepatient. The suction pressure can be decreased from −1.5 to −1.2 psigfor example. The profile is therefore adjusted to drain the patient asquickly, safely and comfortably as possible.

Next, a fill cycle occurs as follows. The control unit causes the vacuumsource to close the drain valve and each of the supply bag (last-bag)valves except for the initial supply bag valve. The control unit alsocauses the vacuum source to open the patient line valve. Gravity forcesfluid from the initial supply bag to the patient's peritoneum. The headheight from the supply bag to the patient will determine the flow rate.This fill flow through 6 mm outside diameter×4 mm inside diameter tubingcan reach 200 ml/min under a twenty-four inch head height and 300 ml/minunder a thirty-six inch head height.

Afterwards, the control unit causes the vacuum source to close allvalves for a dwell period in which the first supply of fluid resides inthe patient's peritoneum, absorbing waste products.

After the dwell, the next drain cycle occurs, and so on. In the nextfill cycle, a different supply bag is used. In the last fill cycle, alast-bag is used, which can contain a lesser or greater amount ofdialysate, and which is intended to dwell in the patient's peritoneumuntil the next therapy session. Each fill and last-bag has its owndedicated control valve in one embodiment.

In a second primary embodiment, gravity is again used to fill thepatient and vacuum is used to drain the patient. Here, the systemincludes a machine or control unit that is placed on a night stand forexample above the patient, e.g., fifteen to forty inches above thepatient. The top of the unit includes a load cell and a heater pan. Adual chamber bag is placed on the load cell/heater pan. The lowerchamber, which resides directly on the heater pan, is a heatingcontainer or warmer pouch, which receives fresh fluid from a supply bag.The upper chamber is a temporary drain container, which receives spentfluid pumped from the patient's peritoneum via the vacuum source. Theupper, temporary drain container of the dual chamber bag is connectedfluidly to a house drain or final drain container, which is locatedelevationally below the dual chamber bag. Spent fluid is gravity fedfrom the dual chamber bag to house drain.

A vacuum-tight cover is placed over the dual chamber bag. Suitablegasketing and locking mechanisms are provided so that the cover can besealed to the unit, around the load cell and heater pan. In this manner,a vacuum can be drawn inside the cover and on the outside the dualcamber bag residing beneath the cover. The cover is configured tosupport one or more supply bag (including a last-bag).

The dual chamber bag includes a valve portion in one embodiment. Forexample, the same sheets or plies used to form the fresh and spentcontainers can be used to form the valve chambers and fluid pathways ofthe valve portion. Or, the same sheets or plies can be used with a rigidpath and valve forming member to form the valve portion. In anotherembodiment, the dual chamber bag is connected fluidly to a separatevalve cassette. In any case, the valve portion or valve cassette isoperable with a valve actuation portion of the control unit. The valveactuators in one embodiment are spring actuated closed and vacuumactuated open (against the spring). In this configuration, the valvesclose in a failsafe manner upon power loss or vacuum source failure.

In this second embodiment, a priming cycle occurs as follows. Thepatient positions the end of the patient line so that its distal end isat substantially the same elevation as the one or more supply bagresiding on top of the vacuum-tight cover. For example, the cover couldinclude a hook onto which the patient hangs the patient line connectorfor priming. The control unit controls the vacuum source so that thevalves to the fresh container of the dual chamber bag and to the patientline are opened. The control unit is programmed to keep these valvesopen for a certain amount of time or until a certain volume of fluid hasgravity flowed to ensure that the fresh container and patient line areprimed with fluid. The dual chamber bag weight is measured and recorded.

Next, a drain from the patient's last-bag fill from night before occurs,while the fill volume in the fresh container of the dual chamber bag viathe prime is heated. Here, the control unit causes the vacuum source to:(i) open a plurality of valves so that spent fluid can flow from thepatient to the spent container of the dual chamber bag (for weighing);and (ii) pulls the last-bag spent fluid from the patient, e.g., at −1.5psig under the vacuum-tight cover, against the head height differencebetween the temporary spent container of the dual chamber bag and thepatient. The volume of fluid pulled from the patient is weighed andknown.

Once the fresh fluid is heated to a desired temperature and all spentlast-bag fluid is pulled from the patient, the weigh scale and controlunit record the combined weight of the fluid in the dual chamber bag.Then, the fill cycle starts and the heated fresh fluid is gravity fed tothe patient. Here, the control unit causes the vacuum source to open oneor more valve, enabling heated fluid from the fresh container of thedual chamber bag to be gravity fed to the patient's peritoneum.

The line from the fresh container of the dual chamber bag to the patientis located at the bottom of the bag, such that air eggressing from theheated fluid floats to the top of the fresh container and only heatedfresh fluid flows from the fresh container to the patient. In analternative embodiment, an integral air separation chamber is providedin communication with the fresh container to collect air eggressing fromthe heated fluid. As fluid exits the heated supply bag, the weigh scaleor load cell weighs and records the amount of fluid that has beendelivered to the patient, which is seen as the loss in weight in thedual chamber bag from the total combined weight of the dual fillsdescribed previously. Once the programmed volume of fluid is deliveredthe patient or the scale no longer senses a drop in weight, the fill tothe patient portion of the fill cycle is completed, one or more valve isclosed, and the weight remaining in the dual chamber bag is recorded bythe weigh scale and control unit. The control unit calculates the drainand fill volumes by subtracting the pre-and post-scale weights for bothdrain and fill cycles.

After completion of the fill-to-patient portion of the fill cycle, thecontrol unit causes the vacuum source to close at least the patient anddrain valves for a dwell period in which the first supply of fluid isallowed to reside in the patient's peritoneum, absorbing waste productsthrough diffusion and osmosis. During the dwell period, the control unitcauses the vacuum source to open one or more valve, enabling fluid fromthe same or different dextrose supply bag to refill the fresh containerof the dual chamber bag, so that it can be preheated for the nextfill-to patient cycle. The increase in weight is again recorded. If ithas not already happened, the control unit can also cause the vacuumsource to open one or more valve, enabling the initial spent last-bagfluid to be gravity fed from the temporary drain chamber of the dualchamber bag to the final drain container or house drain.

After the dwell, the next drain cycle occurs, wherein the vacuum sourcepulls spent fluid from the patient against the head height difference tothe temporary spent container of the dual chamber bag. The incrementalgain of weight due to the fluid reaching the temporary spent containeris recorded. As soon as the first fill of spent fluid is pumped from thepatient, the newly heated fresh fluid can be gravity fed from the freshcontainer of the dual chamber bag to the patient. The incremental lossin weight is recorded as the second fill volume. If the supply bagscontain the prescribed fill volume, the recorded and prescribed volumesserve to double-check one another.

Next, the second dwell period begins and the above-described process isrepeated. Eventually a last-bag volume of fresh dialysate is deliveredto the patient, which is allowed to dwell in the patient until a newtherapy is begun the next day or evening.

Either primary embodiment can be run to perform full fill, dwell anddrain cycles or perform same partially, e.g., in a tidal mode type ofmodality. In the end a difference in the amount of fluid removed fromthe patient versus the amount of fluid delivered to the patient iscalculated and represents ultrafiltrate or UF. The UF therapyprescription is set so that at the end of treatment the patient reacheshis or her “dry weight”. The twenty-four hour UF calculation uses thelast-bag volume from the night before and thus involves filling anddraining from two treatments.

It is therefore an advantage of the embodiments described herein toprovide an improved dialysis system.

It is another advantage of the embodiments described herein to provide agravity fill dialysis system for patients who sleep on the floor or lowto the ground.

It is a further advantage of the embodiments described herein to providea gravity fill dialysis system employing simplified pneumatics and/orhydraulics.

It is yet another advantage of the embodiments described herein toprovide a gravity fill dialysis system that employs a simplifieddisposable set or unit.

It is yet a further advantage of the embodiments described herein toprovide a gravity fill dialysis system that can be adapted for differenttherapy modalities.

It is still another advantage of the embodiments described herein toprovide a gravity fill dialysis system that is relatively gentle on thepatient.

It is still a further advantage of the embodiments described herein toprovide a gravity fill dialysis system that achieves maximum flowrates,allowing for maximum dwell times and clearances.

Moreover, it is an advantage of the embodiments described herein toprovide gravity fill, vacuum drain dialysis system.

Additional features and advantages of the present invention aredescribed in, and will be apparent from, the following DetailedDescription of the Invention and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of one primary embodiment of an automatedperitoneal dialysis system driven by gravity and vacuum.

FIG. 2 is a schematic view of one embodiment for the disposable portion,valve, vacuum lines, electrical lines, control unit and control schemeof the system shown in FIG. 1.

FIG. 3 is a perspective view of one embodiment for the heater andassociated stand of the system shown in FIG. 1.

FIG. 4 is a perspective view of one embodiment of a multi-tube valveactuator used with the automated peritoneal dialysis system driven bygravity and vacuum.

FIG. 5 is a diagram showing the volume of fluid drained versus time ofdrain cycle for two patients.

FIG. 6 is an elevation view of a second primary embodiment of anautomated peritoneal dialysis system driven by gravity and vacuum.

FIGS. 7A and 7B are front elevation and top plan views, respectively, ofone embodiment of a control unit with an integrated heater and load cellfor the system of FIG. 6, wherein a vacuum-tight cover of the system isremoved.

FIGS. 8A and 8B are front elevation and top plan views, respectively, ofthe apparatus of FIGS. 7A and 7B shown with the vacuum-tight cover inplace.

FIG. 9 is a top view of one embodiment for a disposable weigh/supply bagincluding a valve portion and associated tubes of the system shown inFIG. 6.

FIG. 10 is a side view the disposable weigh/supply bag, valve and tubesof FIG. 9.

FIGS. 11 to 14 illustrate one machine configuration for the secondprimary embodiment of the system of FIG. 6.

FIG. 15 illustrates a disposable set that can be used with the secondprimary embodiment.

FIGS. 16 through 19 illustrate various stages in the setup sequence foran alternative arrangement for the second primary embodiment.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIGS. 1 to 3, a first primary embodiment of anautomated peritoneal dialysis (“APD”) system is illustrated by system10. System 10 includes an adjustable stand 12, which in an embodiment ismade of a relatively strong, lightweight and low cost metal or hardplastic. Stand 12 can for example be aluminum, steel or some combinationof metal and plastic. Adjustable stand 12 includes an inner tube or stem14. Inner tube or stem 14 is sized to slide within an outer tube 16. Thepatient or caregiver sets the overall height of stand 12 by moving innertube 14 up or down with respect to outer tube 16 to a desirableposition. Afterward, the patient or caregiver locks the inner tube inplace relative to outer tube 16 via a suitable locking mechanism 18.Outer tube 16 is fastened to, welded to or formed integrally with a setof legs 20, which hold and balance tubes 14 and 16 and the apparatusesconnected thereto. Casters or wheels 22 are coupled at the ends of legs20, so that system 10 can be maneuvered easily. One or more of casters22 can have a locking mechanism to lock system 10 at a desired location.

As seen more closely in FIG. 3, inner tube 14 is connected to andsupports a medical fluid heater 30. Medical fluid heater 30 can use anymode of heat transfer suitable to heat liquid within one or more medicalfluid supply bag, such as resistance plate heating, radiant heating,convective heating, and any suitable combination thereof. Heater 30 inthe illustrated embodiment includes a clam shell construction having alid 32 and a base 34. In an embodiment, the heater elements andassociated heating are located in base 34. Alternatively, the elementsor heating pads are located in lid 32. Further alternatively, theheating elements or pads are located in both lid 32 and base 34.

In the illustrated embodiment, heater 30 is sized and configured to holda pair of supply bags 24 a and 24 b, such that one supply bag 24 a restson top of the second supply bag 24 b. A single supply bag is providedalternatively. Further alternatively, three or more supply bags 24(referring collectively to supply bags 24 a, 24 b, etc.) are provided.One of supply bags 24 can be a last bag that holds a last-bag volume offluid that remains at the end of treatment in the patient's peritoneumuntil the next treatment. Heater 30 can alternately hold two supply bagsplaced side by side with a third bag placed optionally on top of andbetween the bottom two bags.

As illustrated, base 34 defines one or more opening and/or notch 36.Openings 36 enable supply tubes 26 a and 26 b to extend from supply bags24 a and 24 b, respectively, while enabling lid 32 and base 34 to beclosed together tightly around bags 24 a and 24 b. This configurationhelps to prevent supply tubes 26 a and 26 b from becoming crimped.

As seen in FIG. 2, supply bags 24 a and 24 b can include or define oneor more port 28, which is configured to accept a temperature sensingdevice 38 in a sealed manner. Temperature sensing device 38 can be anysuitable device, such as a thermistor, thermocouple or resistancetemperature device (“RTD”) sensor. In the illustrated embodiment,temperature sensing devices 38 measure the temperature of heateddialysis directly. That is, temperature sensing devices 38 actuallycontact the dialysate. In an alternative embodiment, the temperaturesensing devices 38 are located for example on one or more of the innersurfaces of lid 32 and base 34 and contact the bag material instead.Here, the temperature of the bag material is assumed to reach thetemperature of the dialysate over time. Alternatively, if a slightdifference between bag and dialysate temperature is always present, thatdifference can be determined and compensated for.

FIG. 1 shows that outer tube 16 supports a control unit 40. Control 40includes a video monitor 42, such as a liquid crystal display (“LCD”),or other suitable type of display. Video monitor 42 in an embodimentoperates with a touch screen overlay (not illustrated), which enablesthe operator to input commands into control until 40. Alternatively,control unit 40 includes off-screen input devices 44, which can bemembrane switches, knobs, push-buttons or other types ofelectromechanical input devices.

As seen in FIG. 2, video monitor 42 and input devices 44 are connectedand controlled by one or more printed circuit board 46, which includesamong other components random access memory (“RAM”), read only memory(“ROM”) 46 b, a microprocessor 46 c and a power supply 46 d. Code anddata are stored on ROM 46 b and RAM 46 a as is known in the art.Processor 46 c cooperates with RAM 46 a and ROM 46 b to control each ofthe functions of system 10, such as control of heater 30, the control ofultrafiltration removal and the control of the valves of system 10 viaelectrical solenoids 48 a to 48 e. Alternatively or additionally,control unit 40 controls those functions using an application specificcircuit (“ASIC”), solid state relay, MOSFET and the like. Power supply46 d provides the necessary power (amount and type) to solenoids 48 a to48 e and heater 30. To the extent that system 10 includes componentsrequiring different types or ranges of power, a plurality of powersupplies, such as power supply 46 d, can be provided.

Solenoids 48 a to 48 d control valves 52 a to 52 d, respectively ofmulti-way valve assembly 50 via vacuum lines 66 a to 66 e, respectively.Valve assembly 50 in an embodiment includes a housing 54, which definesor provides chambers for valves 52 (referring collectively to valves 52a to 52 d). Housing 54 can be made of plastic or metal as desired. Valveassembly 50 can be attached to or integrated with the housing of controlunit 40.

FIG. 4 illustrates one suitable configuration for multi-way valveassembly 50. Here, valve assembly 50 is a custom manufactured assemblythat is integral with the door of control unit 110 and allows the tubingset (FIG. 15) to be loaded for treatment. Valve assembly 50 provides sixpinch valves 52 a to 52 d (only four used in FIG. 2). Springs 72 pushvalve heads to pinch a tube closed. A vacuum is applied to compresssprings 76 and open a fluid pathway. In FIG. 4, solenoids 48 a to 48 fare mounted with multi-way valve assembly 50. Solenoids 48 a to 48 foperate as described below in connection with FIG. 2.

In FIG. 2, multi-way valve assembly 50 operates directly with supplylines 26 a and 26 b, a patient line 56 (which is connected to a portcoupled to the patient, the patient port coupled fluidly to a catheterthat extends inside the patient to the patient's peritoneal cavity). Afourth drain line 58 runs from the multi-way connection within valveassembly 50 to a drain container 60.

Drain container 60 includes a spent fluid inlet 62 a, which is coupledto drain line 58. Drain container 60 also includes a spent fluid outlet62 b which is coupled to a fifth vacuum line 66 e. A hydrophobicmembrane 64 is placed in outlet 62 b of drain container 60 in oneembodiment to preclude spent fluid from entering vacuum line 66 e. Also,as seen in FIG. 2, inlet 62 a and outlet 62 b of drain container 60 areplaced elevationally at the top of drain container 60, such that spentfluid entering inlet 62 a tends to fall via gravity to the bottom ofdrain container 60 and fill the drain container upwardly. Thus theconfiguration of drain container 60 itself tends to preclude spentdialysate from entering vacuum line 66 e.

A vacuum source 70 is connected to the inlet ends of solenoids 48 a to48 e via a vacuum manifold 72. Vacuum source 70 and manifold 72 areconfigured to maintain a negative pressure on the inlet ends ofsolenoids 48 a to 48 e at all times while vacuum source 70 is powered.Vacuum source 70 in one embodiment includes a vacuum regulator andvacuum pump combining to provide a variable vacuum output, which cansupply a negative pressure to valves 52 a to 52 d and drain container 60from anywhere between zero psig up to −1.5 psig and beyond. One suitablevacuum regulator for vacuum source 70 is an ITV 209 model electronicvacuum regulator provided by SMC Corporation of America, Indianapolis,Ind. The regulator is placed upstream of the vacuum pump in oneembodiment.

In the embodiment illustrated in FIG. 2, valves 52 a to 52 d are springloaded, failsafe valves. Valves 52 a to 52 d each include a plunger 74which is compressed via a spring 76 to pinch or close off patient line56, drain line 58, supply line 26 a and supply line 26 b, respectively.To open one or more of those lines, a vacuum or negative pressure isapplied to the valve source 70, manifold 72, the opening of one or moreelectrically operated solenoid 48 a to 48 e, and the appropriate vacuumline 66 a to 66 d. Valves 52 a to 52 d are said to be failsafe becauseupon a power loss or loss of vacuum, springs 76 cause each of theplungers 74 to close their respective tube or line, precluding anyfurther flow of fresh or spent dialysate.

PCB 46 controls electrically operated solenoids 48 a to 48 e in anembodiment by sending on/off electrical signals to the solenoids overelectrical lines 78 a to 78 e, respectively. The program stored oncontroller or PCB 46 causes electrical signals to open one or more ofsolenoid valves 48 a to 48 e at an appropriate time to establish adesired vacuum flow path and/or draw a vacuum on drain container 60.

As seen in FIGS. 1 and 2, drain container 60 is supported by a scale 80.Scale 80 in turn is connected to mechanical ground 82 via a load cell orstrain gauge 84. Load cell or strain gauge 84 sends a signal tocontroller or PCB 46 via a signal line 86 a. The signal from straingauge 84 can for be example a variable 4 to 20 milliamp or 0 to 10 VDCsignal, which varies depending upon the amount of spent fluid that hasbeen pulled by vacuum to drain container 60. If the strain gage isbumped, an incorrect weight signed will be produced momentarily.Controller or PCB 46 can include averaging routines in its software thataccommodates these anomalies. An accelerometer can be attached to theload cell, so that the controller will know when the load cell has beenbumped. Anomalous readings are then excluded from the averagingroutines. Similar variable signals are also sent from temperaturemeasuring devices 38 along lines 86 b and 86 c, respectively, tocontroller or PCB 46. Controller 46 also receives inputs (e.g., on/off)from manually operated input devices 44 via input signal lines 86 d.

On the output end, besides output lines 78 a to 78 e (e.g., on/off) tosolenoids 48 a to 48 e, respectively, controller 46 controls variablevacuum source 70 via a variable signal along output line 88 a.Controller 46 further controls the output to heater 30 via a variablesignal along outlet line 88 b. In another embodiment, the outlet toheater 30 is an on/off type output, which is varied in frequency tocontrol a duty cycle of heater 30.

Control unit 40 of System 10 is configured to optimize the rate at whichfluid is removed from the patient's peritoneal cavity. Here, the rate atwhich the weight of fluid within drain container 60 changes over time isdetermined by dividing the difference in the signals sent by the straingauge 82 along signal line 86 a to controller 46 by a correspondingdifference in time. The rate can be compared to an optimal rate storedin controller 46. The signal from controller 46 along variable outputline 88 a to variable vacuum source 70 is then adjusted to adjust theamount of vacuum supplied along vacuum line 66 e to drain container 60.The vacuum is adjusted so that the actual rate of change ofultrafiltrate weight measured via strain gauge 84 meets the optimaldrain or ultrafiltrate removal rate.

In operation, system 10 initially performs a priming cycle. Here, thedistill end 90 of patient line 56 is fixed at an elevational level thatis at least substantially the same as supply bags 24 a and 24 b. FIG. 3shows one embodiment for doing so, in which a clip or latch 92 is fixedto the base 34 of heater 30 and is configured to hold the end 90 ofpatient line 56 at a height that is at substantially the same as theheight of supply bags 24 a and 24 b. After the patient fixes patientline 56 as just described, the patient presses an input 44. Control unit40 causes each of valves 52 a to 52 d to be opened at an appropriatetime to enable fresh dialysate to flow through each of supply lines 26 aand 26 b, patient line 56 and drain line 58, flushing air from thoselines.

Because fluid flow through patient line 56 is driven by gravity, thedialysate does not flow above end 90 positioned at the same elevation assupply bags 24 a and 24 b. The prime cycle can be configured such thatcontroller 46 of control unit 40 causes valves 52 a to 52 d to be openedfor a preset amount of time or alternatively until a preset volume offluid is sensed to have flowed through the tubes, after which all valvesclose in one embodiment. The closure of the lines at valve assembly 50prevents fluid from flowing out the distal open end of the lines, e.g.,at inlet 62 a of drain container 60 of drain line 58, due to the weightof the fluid column. The small inside diameter of the tubing used forthe lines precludes air from flowing up into the tubing to relieve avacuum that is created by the weight of the fluid column. Further, theclosed valve assembly does not allow leakage of fluid.

After prime, in one sequence of operation, system 10 performs an initialdrain sequence in which spent dialysate leftover from the previoustherapy is removed initially from the patient's peritoneal cavity. To doso, the patient removes the primed end 90 of patient line 56 from clip92 of heater 30. The patient connects the end 90 to a port stitched intothe patient as is known in the art. The patient then presses an input 44indicating that therapy can begin. For the initial drain, controller 46of control unit 40 causes solenoids 48 a and 48 b to open. Acorresponding vacuum is supplied via vacuum lines 66 a and 66 b tovalves 52 a and 52 b, respectively, to open those valves (pull themclosed against the spring force). No vacuum is supplied to valves 52 cand 52 d, so that the corresponding springs 76 cause the correspondingplungers 74 to pinch close both supply lines 26 a and 26 b.

Simultaneously, controller 46 causes solenoid 48 e to open, which inturn allows a vacuum to be drawn along vacuum line 66 e, throughhydrophobic membrane 64, and into the chamber of drain container 60. Thevacuum in drain container 60 pulls fluid from the patient's peritonealcavity, through patient line 56, through drain line 58 and intocontainer 60, where it begins to fill to the container. As discussedabove, feedback from strain gauge 84 cooperates with controller 46 andvariable vacuum source 70 to optimize the rate at which fluid is pulledfrom the patient to drain container 60. Because the patient drain isdone via vacuum, the patient can be at a lower elevational level thandrain container 60, at the same level, or at a higher elevational levelthan drain container 60 that would nevertheless not be sufficient todrain the patient efficiently via gravity.

The drain cycle in one embodiment is preformed using a profile, whichoptimizes the flow of fluid from the patient's peritoneum to draincontainer 60 to ensure that the patient is maintained in a comfortablestate. To do so, drain flowrate is calculated from volume measurementsin one embodiment to determine when the patient may be susceptible todiscomfort. For example, the profile could divide the drain cycle intotwo phases, one which is a higher flow phase and another which is alower flow phase. When the patient reaches the lower flow phase, thevacuum is adjusted to account for discomfort, which may occur at thatlower flow.

At the beginning of the drain cycle, the high flow phase can beperformed using a relatively low suction pressure because the source ofspent fluid is relatively abundant and flows readily and smoothly fromthe patient's peritoneal cavity. As the patient's peritoneum becomesmore and more empty, and the source of spent fluid becomes increasinglyless abundant, the drain flow starts to slow down. FIG. 5 illustratesthe “break point” concept that is understood in the art as a change indrain flow rate, which indicates that the peritoneum is relativelyempty. System 10 then decreases the suction pressure to prevent it fromcausing pain to the patient. For example, the suction pressure isdecreased from −1.5 psig to −1.2 psig. The profile is in this wayadjusted to drain the patient as quickly, safely and comfortably aspossible.

Each patient can vary in terms of when the low flow phase occurs and howfar the drain flowrate drops. For example, one patient may transitionfrom the high flow phase to the low flow phase after 70% of their fillvolume has been drained, whereas another patient may not transitionuntil 90% of their fill volume has been drained. Also, the firstpatient's flow rate may drop to below 50 ml/min, while the secondpatient's flow rate may drop to below 25 ml/min when reaching the lowflow phase.

The chart of FIG. 5 illustrates how patient drain rates can vary. Here,the initial drain rates for two patients are constant and track closelytogether for the first ten minutes of the drain cycle. At this time, andat a remaining volume of about 900 ml, the first patient's drain rateslows considerably over a “move-on” time of about eight minutes, atwhich point the drain cycle is stopped with approximately 550 ml offluid remaining in the patient's peritoneum. The higher drain rate forthe second patient on the other hand continues to about 13.5 minutes. Atthis time, and at a remaining volume of about 300 ml, the secondpatient's drain rate slows considerably over a “move-on” time of aboutfive minutes, at which point the drain cycle is stopped withapproximately 150 ml of fluid remaining in the patient's peritoneum.

Based on the above-described physiological characteristics of thepatient, the transition in suction pressure is made based upon acombination of flowrate and volume of fluid drained. Also, the “move-on”time needs to be adjusted so that the patient does not unduly wastetherapy dwell time attempting to drain the last drop of spent fluid.

The first fill cycle is then performed. In one embodiment, the fillcycle begins automatically after the initial drain, so that the patientcan be asleep during this portion of the therapy if desired. In the fillcycle, controller 46 of control unit 40 causes either solenoid 48 c or48 d to open, enabling a vacuum to open one of supply lines 26 a or 26 bvia a respective valve 52 c or 52 d. Also, controller 46 causes solenoid48 a to open, enabling a vacuum to open patient valve 52 a. Freshdialysate is then enabled to flow from one of the supply bags 24 a or 24b, through the interface at multi-way valve assembly 50, through patientline 56, and into the peritoneal cavity of the patient. The flow offluid in the patient fill is performed via gravity. Accordingly, supplybags 24 a and 24 b should be set via tubes 14 and 16 and locking device18 to be at a minimum head height distance above the patient'speritoneal cavity, such as 3 ft. (0.9 m) above the peritoneal cavity.Assuming an inner diameter of 4 mm for supply lines 26 a and 26 b andpatient line 56, the gravity fed flow of dialysate will reach over 200ml/min and could reach as high as 300 ml/min.

After the known amount of fresh fluid is delivered to the patient, adwell cycle occurs in which the fresh fluid is allowed to dwell withinthe patient's peritoneum, while diffusive and osmotic forces removewaste and excess water from the patient. The dwell period can be variedas needed but generally lasts for one to two hours depending upon thedialysis therapy prescription. After the dwell cycle occurs, the above,drain, fill and dwell cycles are repeated one or more times asprescribed by a physician. The final fill can be performed using alast-bag, which delivers a final amount of fluid to the patient. Thatfinal amount of fluid resides within the patient's peritoneal cavityuntil the next time therapy is performed. System 10 also includes one ormore pressure and/or flow sensor used for alarm purposes, e.g., todetect a kinked or detached line. The pressure/flow sensor can beconfigured to sense the pressure/flow of at least one of the patientline, the drain line, the supply line and any one of the vacuumlines/manifold.

At the end of therapy, the total amount of fluid collected in container60 is known. Further, the total amount of fluid delivered from supplybags 24 a and 24 b, assuming all fluid is delivered from the supply bagsto the patient, is also known. The additional weight of spent fluid incontainer 60 over that delivered from supply bags 24 to the patient isknown as ultrafiltrate, which is the excess fluid or water that isretained by the patient between treatments due to renal failure. Becausea good portion of the fluid within container 60 is from the previoustherapy's last-bag or last fill, the twenty-four hour ultrafiltratevolume takes into account the previous night's volume of last fill,which is typically close or equal to the last-bag fill of the instanttherapy.

In an embodiment, the connection of drain line 58 and vacuum line 66 eto inlet and outlet 62 a and 62 b, respectively, of drain container 60is done via a quick disconnect or other readily assembled anddisassembled connection. This is done so that the patient or caregiverin the morning or otherwise after therapy can disconnect drain container60 readily from those lines to pour its contents into a house drain,such as a toilet. Scale 80 is accordingly configured such that draincontainer 60 can be removed from and reloaded into same readily.

Referring now to FIGS. 6 to 19, a second primary embodiment of a systemdriven by gravity and vacuum is illustrated by system 100. System 100includes many of the same components as does system 10. Where possible,these components are numbered the same. For example, system 100 includesa patient line 56 having a distill end 90. System 100 also includes adrain line or tube 58. System 100 further includes one or more supplybag 24 (referring generally to one of supply bags 24 a, 24 b, etc.).Supply bag 24 communicates fluidly with a supply line 26. System 100differs in one respect from system 10 in that the load cell measuresboth the volume fluid that is delivered to the patient and the volume offluid that is drained from the patient.

System 100 also includes valves that allow fluid to flow to a desireddestination during a particular cycle during therapy. The valves in oneembodiment are failsafe, spring/vacuum actuated valves, such as valves52 a to 52 d shown in connection with FIG. 10. Those valves are locatedinside of a control unit 110 of system 100. The valves within controlunit 110 include a spring actuator, such as spring 76 and plunger orpincher, such as plunger 74 of system 10. The opening and closing of thevalves of system 100 in one embodiment is the same as that describedabove in connection with system 10. Accordingly, it is not necessary tore-illustrate show or re-describe such operation.

Similarly, system 100 includes a heater 130 and load cell 184. Heater130 can be of any of the types of fluid bag warmers described above forheater 30. Heater 130 in system 100 however is located on the top ofcontrol unit 110. The heater pan is placed on or is incorporated with aload cell 184. Load cell 184 performs the same function in system 100 asstrain gauge 84 of system 10. That is, load cell 184 measures the weightof fluid pulled by vacuum into a dual chamber bag 120. Hereadditionally, load cell 184 measures the weight of fresh dialysatesupplied to the patient. Load cell 184 in system 100 is configured tosend a signal to a controller or PCB (configured with each of thealternatives described above for PCB 46) located within control unit 110based on a compressive force due to the weight of fluid within dualchamber bag 120 (in the illustrated embodiment of system 10, straingauge 84 provides a signal based on a tensile force applied to scale 80via the weight of fluid drawn into control container 60). Thus whileheater 130 and load cell 184 provide similar functions as heater 30 andload cell 84, their physical configuration and operation are different.

As illustrated, control unit 110 includes input devices 44 and a videomonitor 42 as described above in connection with control unit 40 ofsystem 10. The electrical layout of FIG. 2 for system 10 is also largelyapplicable to the electrical layout of system 100, which is housedinside control unit 110. That is, a PCB including RAM, ROM, amicroprocessor (ASIC or MOSFET) and one or more power supply receivesvarying amperage or voltage signals from load cell 184 and one or moretemperature measuring device (not illustrated), which measures thetemperature of fresh dialysate located within a fresh container 122 ofdual chamber bag 120 directly or at the outer surface of bag 120directly adjacent to the heated supply within fresh container 122.

The electrical scheme of system 100 also includes a variable electricaloutput to a variable vacuum source (similar to that provided along line88 a to variable vacuum source 70 of system 10 shown in FIG. 2).Moreover, the controller or PCB of system 100 sends a variable or dutycycle output to heater 130 (as is done in connection with controller 46and heater 30 of system 10). Control unit 110 in an embodiment housingselectrically actuated solenoids (such as solenoids 48 a to 48 e ofsystem 10), which allow or disallow a vacuum to be applied along vacuumlines (such as lines 66 c to 66 e of system 10) to the valves (describedabove) and to a vacuum chamber established beneath a vacuum tight cover102 (shown in FIGS. 8A, 8B, 18 and 19). System 100, like system 10,includes necessary vacuum lines, which in an embodiment are housedinside control unit 110.

Cover 102 is sealed via seal 104 located around the outside of load cell184 and heater 130 to the top of control unit 110. Seal 104 can be asoft rubber or sponge rubber seal, for example neoprene rubber or closedcell sponge silicone rubber. Seal 104 could also be constructed of anelastomer, which is extruded or molded in a geometric shape that sealswell under a vacuum. A V-shaped gasket with its open side facingatmospheric pressure is one example of a suitable geometric vacuum seal.The weight of the cover may be sufficient to hold the cover in place.Clamping devices 106, such as spring loaded twist clamps, can also beprovided to hold cover 102 in a sealed relationship with the top ofcontrol unit 110. In an embodiment, hinges 108 are provided such thatcover 102 swings hingedly up from the top of control unit 110. Theweight of fluid within supply bag 24 also helps to seal cover 102against the top of control unit 110. That weight may be enough tomaintain the seal under the relatively low negative pressures used insystem 100, e.g., on the order of between 0 and −1.5 psig. Also, thenegative pressure itself would tend to pull lid 102 into the gasket 104,precluding the need for clamping devices 106 and/or hinges 108.

System 100 can also include a reusable drain container or disposabledrain bag (not illustrated and referred to hereafter as drain containerfor simplicity), which connects to and communicates fluidly with drainline 58. In system 100 however the drain container is not weighted andis not used in the same way as in system 10 to determine and controlultrafiltration removal. The drain container of system 100 here is usedto collect spent dialysate. It is configured to be located beneathcontrol unit 110, so that spent fluid from spent container 124 of dualchamber bag 120 can be gravity fed to the drain container.

The control of fluid volume removed and flowrate is done using dualchamber bag 120, load cell 184 and the switching of valves (which arespring closed and vacuum opened in one embodiment as described above inconnection with valves 52 a to 52 d of FIG. 10). As seen in FIGS. 9 and10, dual chamber bag 120 includes a heated container 122 and a temporaryspent container 124. In an embodiment, flexible membranes used to formheating supply and temporary drain bag containers 122 and 124,respectively, of dual chamber bag 120 are also used to form at least aportion of valve portion 128. Flow paths 126 a to 126 d for example canbe thermal formed and one of the upper or lower plies of dual chamberbag 120. In an alternative embodiment, two of the plies used to formcontainers 122 and 124 are sealed to a rigid member to form valveportion 128. Further alternatively, valve portion 128 is separate frombag 120 and connected fluidly thereto via separate tubes forming part offlow paths 126 a to 126 d.

Flow paths 126 a to 126 d each communicate fluidly with a valve seat 136a to 136 d, respectively. An additional valve seat 136 e is placed atthe intersection of flow paths 126 b, 126 c and patient line 56 forreasons discussed below. Heated fresh container 122 communicates fluidlywith supply line 26 and flow paths 126 a and 126 b. Temporary spentcontainer 124 communicates fluidly with drain line 58 and flow paths 126c and 126 d. Both containers 122 and 124 communicate fluidly withpatient line 56, necessitating fifth valve 136 e.

As seen in FIG. 6, control unit 110 is placed on a nightstand or otherlocation that is elevationally above the patient's peritoneum. Dualchamber bag 120, resides above control unit 110, and therefore residesabove the patient's peritoneum. Further, supply bag 24 is placedelevationally above dual chamber bag 120 and can gravity fill dualchamber bag 120. Dual chamber bag 120 in turn can gravity fill thepatient's peritoneum. Furthermore, as discussed before, spent dialysatestored temporarily in spent container 124 of dual chamber bag 120 can begravity filled into the drain container or drain bag located for exampleon the floor of the bedroom or other room in which therapy is takingplace.

FIGS. 11 to 19 illustrate one configuration and set-up sequence forsystem 100. FIG. 11 illustrates that load cell 184 is mounted to a baseplate 186. In one embodiment, load cell 184 is a dual load cell, whichprovides redundancy. Plate 186 can be hard plastic or metal, e.g.,stainless steel, steel or aluminum. FIG. 12 illustrates that a heatedbag holder 130 is mounted to load cell 184. Heated bag holder 130includes heating elements (not illustrated) that heat a tapered bottom132 and sides 134 forming the holder. Tapered bottom 132 tips the bagsdownwardly towards the open (line connection) end of heated bag holder130, which helps to direct fluid out of bags 122 and 124. The transitionfrom bottom 132 to sides 134 is chambered or rounded to help supportbags 122 and 124 and increase heater contact area.

FIG. 13 illustrates that multi-way valve assembly 50 is also mounted tobase plate 186. Multi-way valve assembly 50 can be the six pinch valveunit shown and described in connection with FIG. 4. FIG. 14 shows plate186, heated bag holder 130 and multi-way valve assembly 50 mounted intocontrol unit 110. Control unit 110 includes video monitor 42 and inputdevices 44 as described herein. Control unit also includes or defines aslot 112 for connecting patient line 56 and drain line 58 to heating bag122 and drain bag 124, respectively. Control unit also includes ordefines a line holder 114, e.g., a press-fit line holder, for fixingdistal end 90 of patient line 56 for priming.

FIG. 15 shows one configuration for a disposable set 190 of system 100.Disposable set 190 includes patient line 56 and drain line 58, which areconnected fluidly to a cross 188. Supply line 26 tees into patient line56 at tee 192. Patient line 56 is connected to cross 188 via elbow 194,which orients the lines properly for the loading of the area of cross188 of disposable set 190 into control unit 110. The distal ends oflines 26, 56 and 58 are provided with connectors and clamps as needed.

FIGS. 16 to 19 show a slightly different configuration for the secondprimary embodiment of system 100. Here, a separate heating bag 122 andsupply bag 124 are used instead of dual chamber bag 120 having separatecontainers 122 and 124. FIG. 16 shows that the area of cross 188 ofdisposable set 190 has been loaded into control unit 110, and inparticular behind the hinged door of multi-way valve assembly 50. Thelines are placed in operable position with selected pinch valves ofmulti-way valve assembly 50 so that they can be opened and closedselectively. Distal end 90 of patient line 56 is fitted into line holder114 for priming. Heating bag 122 is placed in and supported by heatedbag holder 130. Patient line 56 is connected to the heating bag.

In FIG. 17, empty, interim drain bag 124 is placed onto heating bag 122.Drain line 58 is connected to the drain bag. As discussed above, in thisconfiguration heating bag 122 and drain bag 124 are separate bags asopposed to being part of a single dual chamber bag 120. Eitherconfiguration can be used. Here, the previous day's supply bag can beused as the current day's empty interim weigh bag to reduce cost and thevolume of disposable waste. In FIG. 18, cover 102 is placed over bags122 and 124. In FIG. 19, supply bag 24 is placed onto cover 102. Supplyline 26 is connected to supply bag 24. System 100 is now ready to beprimed.

Whether or not dual chamber bag 120 is used or separate bags 122 and 124are used, in the priming cycle of system 100, valve seats 136 a to 136 eare each opened allowing the fluid to flow throughout each of the lines.The priming purges all of the lines of air including the patient line56. The absence of air in the lines allows load cell 184 to accuratelymeasure the volume of fluid delivered to the patient and drained fromthe patient and also prevents the delivery of air to the patient. Theprime does not have to fully fill heater bag 122 or dual chamber bag 120because gravity will prevent air from being delivered from heated freshcontainer or bag 122 to the patient. Heated fresh container or bag 122may be provided with a vent (not illustrated), for example including ahydrophobic membrane, which allows air to be purged from container 122as it is filled with fluid.

The controller or PCB within control unit 110 causes the vacuum sourceto open the valves at valve seats 136 a and 136 e, which enables freshfluid to flow from supply bag 24, through supply line 26, through flowpath 126 a, into and filling lower supply container 122 of dual chamberbag 120 (or separate bag 122), which contacts heater 130, through flowpath 126 b, through patient line 56 to distal end 90. As above withsystem 10, system 100 includes an apparatus that holds distal end 90 ofpatient line 56 at least substantially at the same elevational height assupply bag 24 during the prime cycle period. When prime is complete thepatient connects distal end 90 of patient line 56 to the port stitchedinto the patient, which port communicates via an inserted catheter withthe patient's peritoneum. During prime, the heating of fresh dialysatewithin supply container or bag 122 can begin.

As with system 10, the next step in the therapy in one embodiment is toremove the last-bag volume from the patient's last treatment. Beforethis is done, however, the weight of fresh fluid that has entered freshcontainer or bag 122 is noted. Afterwards, the vacuum source is allowedto: (i) open the valves at valve seats 136 c and 136 e and (ii) draw avacuum within vacuum type cover 102 (valves at valve seats 126 a and 126b opened previously for prime are now closed). This action causes spentfluid to be pulled from the patient's peritoneum, through line 56, andinto temporary spent container 124 of dual chamber bag 120. Thus at thesame time a batch of fresh dialysate from the prime is being heated, theprevious last-bag volume can be pulled from the patient. The additionalweight of spent fluid entering dual chamber bag 120 is noted.

As soon as the volume of fluid in supply container 122 is heated to itsdesired temperature, it can be delivered to the patient (assuming thisdoes not occur before the last-bag volume is removed completely from thepatient). Assuming that the heating takes longer than the last-bagremoval, the temporary spent container 124 can be drained to the drainbag while the fresh fluid in the fresh container 122 is being heated.Here, control unit 110 causes the valve operating with valve seat 136 dto open path 126 d, enabling spent fluid to gravity drain from thetemporary spent container 124 to the drain bag. If this portion of thedrain occurs before the fill occurs, the drop in weight within dualchamber bag 120 can be noted via the load cell 184, so that adouble-checking of the amount of fluid delivered to and from eachcontainer 122 and 124 can be made.

Once the fresh fluid in container 122 is heated to its desiredtemperature, the heated fresh dialysate is delivered through flow path126 b, passed valve seats 136 b and 136 e, through patient line 56 andinto the patient's peritoneum. Gas eggressing from the dialysate as itsbeing heated collects at the top of fresh container 122. The interfacebetween flow path 126 b and fresh container 122 is therefore located ator near the bottom of fresh container 122, such that only liquid flowsfrom container 122 through patient line 56. After the known amount offresh fluid is delivered to the patient, a dwell cycle occurs in whichthe fresh fluid is allowed to dwell within the patient's peritoneum,while diffusive and osmotic forces remove waste and excess water fromthe patient. The dwell period can last for one to two hours for exampledepending upon the dialysis therapy prescription.

Depending on the state of dual chamber bag 120 or separate bags duringthe dwell period, different fill, drain and valving sequences can occur.For example, if not already done, the controller of system 100 duringthe dwell cycle can cause the last-bag spent dialysate residing intemporary spent container or bag 124 to be gravity fed into the draincontainer. This second half fill can occur while a second fill of freshdialysate into container 122 or bag occurs for heating. The drain of theinterim spent container or bag 124 can occur simultaneously with thereplenishing of the fresh container or bag 122 or sequentially sincethese weights are not required for the calculation. Once the first fillis removed form the patient and the second fill is heated to its desiredfluid temperature, the second fill can be delivered to the patient for asecond dwell period and so on.

More than likely, the initial last-bag volume has been sent to the finalspent container before the first dwell occurs, so a second batch offresh dialysate can be delivered from supply bag 24 to fresh containeror bag 122 of dual chamber bag 120 for heating. Because temporary spentcontainer or bag 124 is empty when this happens, system 100 knows theweight of the second fill fluid is equal to the weight in container orbag 122 at the end of the second fill. When the first dwell period isover, spent fluid is vacuum driven to temporary spent container or bag124, while fluid is being heated within fresh container or bag 122. Oncethe first fill is removed form the patient and the second fill is heatedto its desired fluid temperature, the second fill can be delivered tothe patient for a second dwell period and so on. System 100 can delivera last-bag volume at the end of treatment, which operates as describedabove.

Both systems 10 and 110 can perform a tital flow peritoneal dialysistreatment as an alternative to the batch type therapies just described.In tital flow systems, only a portion of the spent fluid is removed fromthe patient's peritoneum. The removed spent portion is back filled withfresh fluid. The partial exchanges occur more frequently than is donetypically with batch type therapies. Tital flow therapies areaccordingly more continuous.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present invention andwithout diminishing its intended advantages. It is therefore intendedthat such changes and modifications be covered by the appended claims.

1. A peritoneal dialysis machine comprising: a supply bag; an apparatusconfigured to support the supply bag, the supply bag located above theperitoneal cavity of a patient; a patient line configured to beconnected to the patient; a drain line configured to be connected to adrain; a vacuum source configured to operate at least one of a patientline valve positioned to open and close the patient line and a drainline valve positioned to open and close the drain line; and a logicimplementor configured to: (i) enable fresh dialysate to be gravity fedfrom the supply bag through the patient line to the peritoneal cavityduring a fill cycle; (ii) enable the vacuum source to cause spentdialysate to be pulled from the peritoneal cavity through the drain lineto the drain during a drain cycle; and (iii) control at least one of thepatient line valve positioned to open and close the patient line and thedrain line valve positioned to open and close the drain line.
 2. Theperitoneal dialysate machine of claim 1, which includes a heaterconfigured and arranged to heat the fresh dialysate while in the supplybag.
 3. The peritoneal dialysis machines of claim 1, wherein the logicimplementor is further configured to enable at least one of: (i) freshdialysate to be gravity fed from the supply bag to a distal end of thepatient line during a prime cycle; (ii) dialysate to be maintainedwithin the peritoneum for a period of time during a dwell cycles; and(iii) the fill and drain cycles to be repeated at least one time.
 4. Theperitoneal dialysis machine of claim 1, which includes a patient lineholder configured to hold an end of the patient line.
 5. The peritonealdialysis machine of claim 4, wherein the supply bag supporting apparatussupports the patient line holder.
 6. The peritoneal dialysis machine ofclaim 1, which includes an enclosure housing the vacuum source, theenclosure providing a user-machine interface operable with the logicimplementor.
 7. The peritoneal dialysis machine of claim 6, wherein thesupply bag supporting apparatus: (i) includes a stand that also supportsthe enclosure; (ii) is a top of the enclosure; or (iii) is configured tosupport a heater separate from the enclosure.
 8. The peritoneal dialysismachine of claim 1, which includes at least one other component selectedfrom the group consisting of: (i) at least one solenoid valve operablewith the vacuum source; (ii) a load cell configured to weigh at leastone of the supply bag and the drain bag; (iii) a disposable cassette influid communication with at least one of the patient line and the drainline; (iv) a valve actuator operable to open and close at least one ofthe patient line and the drain line; and (v) at least one pressuresensor configured and arranged to sense a pressure of at least one ofthe patient line, the drain line and the vacuum source.
 9. Theperitoneal dialysis machine of claim 1, wherein the drain includes: (i)a reusable container or (ii) a disposable bag.
 10. The peritonealdialysis machine of claim 1, wherein the vacuum source is in pneumaticcommunication with the drain, and the logic implementor is configured toenable the vacuum source to apply a negative pressure to the drain tocause the spent dialysate to be pulled from the peritoneal cavity duringthe drain cycle.
 11. The peritoneal dialysis machine of claim 1, whereinthe vacuum source is in pneumatic communication with a chambersurrounding the drain, and the logic implementor is configured to enablethe vacuum source to apply a negative pressure to the chamber to causethe spent dialysate to be pulled from the peritoneal cavity during thedrain cycle.
 12. The peritoneal dialysis machine of claim 1, whichincludes a plurality of supply bags configured to gravity feed freshdialysate through the patient line to the peritoneal cavity.
 13. Theperitoneal dialysis machine of claim 1, which includes a fill bag, thelogic implementor configured to replenish the supply bag from the fillbag after the fill cycle.
 14. The peritoneal dialysis machine of claim1, wherein the logic implementor is configured to control the vacuumsource during the drain cycle so that dialysate can be removed from theperitoneal cavity at different flowrates.
 15. A peritoneal dialysismachine comprising: a supply bag; a scale supporting a drain; a heaterconfigured to support and heat the supply bag; an apparatus configuredto support the heater and the supply bag, the heater and the supply baglocated above the peritoneal cavity of a patient; a patient lineconfigured to be connected to the patient; a drain line configured to beconnected to the drain; a vacuum source in pneumatic communication withthe drain and configured to operate at least one of a patient line valvepositioned to open and close the patient line and a drain line valvepositioned to open and close the drain line; and a logic implementorconfigured to: (i) enable fresh dialysate to be gravity fed from thesupply bag through the patient line to the peritoneal cavity during afill cycle; (ii) enable the vacuum source to cause spent dialysate to bepulled from the peritoneal cavity through the drain line to the drainduring a drain cycle; and (iii) control at least one of the patient linevalve positioned to open and close the patient line and the drain linevalve positioned to open and close the drain line.
 16. The peritonealdialysis machine of claim 15, wherein the logic implementor is furtherconfigured to enable at least one of: (i) fresh dialysate to be gravityfed from the supply bag to a distal end of the patient line during aprime cycle; (ii) dialysate to be maintained within the peritoneum for aperiod of time during a dwell cycle; and (iii) the fill and drain cyclesto be repeated at least one time.
 17. The peritoneal dialysate machineof claim 15, wherein the supply bag supporting apparatus supports apatient line holder configured to hold an end of the patient line. 18.The peritoneal dialysis machine of claim 15, wherein the supply bagsupporting apparatus additionally supports an enclosure housing at leastone of the vacuum source and the logic implementor.
 19. The peritonealdialysis machine of the claim 15, which includes at least one othercomponent selected from the group consisting of: (i) at least onesolenoid valve operable with the a vacuum source; (ii) a load cellconfigured to weigh the drain; (iii) a multi-way valve in fluidcommunication with at least one of the patient line and the drain line;and (iv) at least one pressure sensor configured and arranged to sense apressure of at least one of the patient line, the drain line and thevacuum source.
 20. The peritoneal dialysis machine of claim 15, whereinthe drain includes at least one of: (i) an enclosed structure configuredto withstand the applied negative pressure; and (ii) a filter enablingair but not dialysate to flow from the drain to the vacuum line.
 21. Theperitoneal dialysis machine of claim 15, which includes a plurality ofsupply bags configured to gravity feed fresh dialysate through thepatient line to the peritoneal cavity.
 22. The peritoneal dialysismachine of claim 15, wherein the logic implementor is configured tocontrol the vacuum source during the drain cycle so that dialysate canbe removed from the peritoneal cavity at different flowrates.
 23. Aperitoneal dialysis machine comprising: a fresh dialysate container; anapparatus configured to support the fresh container, the fresh containerlocated above the peritoneal cavity of a patient; a patient lineconfigured to be connected to the patient; a spent dialysate container,the fresh and spent dialysate containers coupled fluidly to a disposablevalve portion having at least one of a patient line valve seat and adrain line valve seat; a vacuum source in pneumatic communication with achamber surrounding the spent container and configured to operate apatient line valve positioned to open and close the patient line; and alogic implementor configured to enable: (i) fresh dialysate to begravity fed from the fresh container through the patient line to theperitoneal cavity during a fill cycle; and (ii) the vacuum source toapply a negative pressure to the chamber to cause spent dialysate to bepulled from the peritoneal cavity to the spent container during a draincycle.
 24. The peritoneal dialysis machines of claim 23, wherein thelogic implementor is further configured to enable at least one of: (i)fresh dialysate to be gravity fed from the fresh container to a distalend of the patient line during a prime cycle; (ii) dialysate to bemaintained within the peritoneum for a period of time during a dwellcycle; and (iii) the fill and drain cycles to be repeated at least onetime.
 25. The peritoneal dialysis machine of claim 23, wherein the freshand spent containers are configured as part of a dual chamber bag housedbeneath the chamber.
 26. The peritoneal dialysis machine of claim 23,wherein the fresh and spent containers are configured as separate supplyand drain bags.
 27. The peritoneal dialysis machine of claim 23, whereinthe supporting apparatus includes at least one of a heater pan and aload cell connected operably to the logic implementor.
 28. Theperitoneal dialysis machine of claim 27, which is configured such thatthe fresh container is placed on the heater pan.
 29. The peritonealdialysis machine of claim 28, which is configured such that the spentcontainer is placed on top of the fresh container.
 30. The peritonealdialysis machine of claim 23, which includes at least one othercomponent selected from the group consisting of: (i) at least onesolenoid valve operable with the vacuum source; (ii) a load cellconfigured to weigh at least one of the fresh container and the spentcontainer; (iii) a valve actuator operable to open and close at leastone of the patient line and the drain line; and (iv) at least onepressure sensor configured and arranged to sense a pressure of at leastone of the patient line, the drain line and the vacuum source.
 31. Theperitoneal dialysis machine of claim 23, which includes a fill bag, thelogic implementor configured to replenish the fresh container from thefill bag after the fill cycle.
 32. The peritoneal dialysis machine ofclaim 23, which includes a drain connected fluidly to the spentcontainer.
 33. The peritoneal dialysis machine of claim 23, whichincludes a weigh scale operable with the logic implementor, the weighscale configured to sense at least one of: (i) an amount of freshdialysate delivered during the fill cycle and (ii) an amount of spentdialysate returned during the drain cycle.
 34. The peritoneal dialysismachine of claim 1, wherein the at least one patient line valve anddrain line valve includes a plunger and a spring configured to bias saidplunger to close the at least one valve, and wherein the vacuum sourceis configured to apply a vacuum to the at least one valve to open theleast one valve.
 35. The peritoneal dialysis machine of claim 15,wherein the at least one patient line valve and drain line valveincludes a plunger and a spring configured to bias said plunger to closethe at least one valve, and wherein the vacuum source is configured toapply a vacuum to the at least one valve to open the least one valve.36. The peritoneal dialysis machine of claim 15, wherein the apparatusincludes a stand having an upper portion and a lower portion, the upperportion of the stand connected to and supporting a base of the heaterand the lower portion supporting the scale.